510(k) Report

FDA applicant

Hana Biologics, Inc.

Walker, MI8 decisions1981–19880 recalls

FDA records 8 decisions for Hana Biologics, Inc. (Walker, MI) from 1981 to 1988: 8 510(k) clearances. Most are in product codes JSI (Culture Media, Selective And Differential) and KIT (Media And Components, Synthetic Cell And…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Hana Biologics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hana Biologics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hana Biologics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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